perioperative gemcitabine, cisplatin, and pembrolizumab in potentially resectable biliary tract cancers

Conditions: Billiary Track Cancer

Summary: the purpose of this study is to determine the safety of peri-operative gemcitabine, cisplatin, and pembrolizumab in patients with btc, as well as whether the combination of gemcitabine, cisplatin, and pembrolizumab (gem/cis/pembro) is feasible and lead to pathologic responses.


Eligibility criteria:
inclusion criteria: * must have a newly diagnosed, biopsy-proven biliary tract cancer (btc) including gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma. * resectable btc (biliary tract cancer) * measurable disease per recist 1.1 as determined by the investigator. * age ≥18 years. * ecog (eastern cooperative oncology group) performance status ≤1 or karnofsky ≥80 * patients must have adequate organ and marrow function defined by study-specified laboratory tests. * patients must have adequate liver function defined by study-specified laboratory tests. * patients with chronic or acute hbv or hcv infection must have disease controlled prior to enrollment. * women of childbearing potential (wocbp) must have a negative urine or serum pregnancy test. * for both women and men, must use acceptable form of birth control while on study. * ability to understand and willingness to sign a written informed consent document. exclusion criteria: * receiving, or previously received, any systemic chemotherapy, or investigational agent for btc. * has received prior radiotherapy within 2 weeks of start of study intervention. * patients with a history of prior treatment with anti-pd-1 and anti-pd-l1. * have been diagnosed with another cancer or myeloproliferative disorder whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study's investigational drugs. * has a known history of human immunodeficiency virus (hiv)/aids * has active co-infection with hbv and hdv. * has a diagnosis of immunodeficiency. * has active autoimmune disease that has required systemic treatment in the past 2 years. * systemic or topical corticosteroids at immunosuppressive doses. * prior allogeneic stem cell transplantation or organ transplantation. * prior tissue or organ allograft or allogeneic bone marrow transplantation, including corneal transplants. * uncontrolled intercurrent active medical and/or psychiatric illness/social psychosocial problems that that would limit compliance with study requirements. * uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements. * evidence of clinical ascites. * has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * previously identified allergy or hypersensitivity to monoclonal antibodies or any component of the study treatment formulations. * pregnant or breastfeeding. * wocbp and men with female partners (wocbp) who are not willing to use contraception. * subjects unable to undergo venipuncture and/or tolerate venous access. * patient is at the time of signing informed consent a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).

Keywords: biliary tract cancer pembrolizumab gemcitabine cisplatin immunotherapy potentially resectable biliary tract cancer anti pd-l1 pd-l1 carcinoma